Pharmacology and Safety of Glycerol Phenylbutyrate in Healthy Adults and Adults with Cirrhosis Publication Pharmacology and Safety of Glycerol Phenylbutyrate in Healthy Adults and Adults with Cirrhosis Phenylbutyric acid (PBA), which is approved for treatment of urea cycle disorders (UCDs) as sodium…CertaraJune 1, 2010
Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-like Peptide-2 Analog in Neonates and Infants with Short-bowel Syndrome Publication Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-like Peptide-2 Analog in Neonates and Infants with Short-bowel Syndrome Teduglutide, a synthetic glucagon-like peptide-2 (GLP-2) analog with activity relating to the regeneration, maintenance, and…CertaraDecember 1, 2009
Population-based Mechanistic Prediction of Oral Drug Absorption Publication Population-based Mechanistic Prediction of Oral Drug Absorption The bioavailability of drugs from oral formulations is influenced by many physiological factors including gastrointestinal…CertaraJune 1, 2009
Enriched Analgesic Efficacy Studies: An Assessment by Clinical Trial Simulation Publication Enriched Analgesic Efficacy Studies: An Assessment by Clinical Trial Simulation The aim of this study was to develop a pain relief model for a cyclooxygenase…CertaraApril 1, 2006
The Use of Clinical Trial Simulation to Support Dose Selection: Application to Development of a New Treatment for Chronic Neuropathic Pain Publication The Use of Clinical Trial Simulation to Support Dose Selection: Application to Development of a New Treatment for Chronic Neuropathic Pain Pregabalin is being evaluated for the treatment of neuropathic pain. Two phase 2 studies were…CertaraNovember 1, 2003